Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Why The EU Urgently Needs A One-Year Delay For The IVDR And EU-Wide Exceptions For IVDs

Executive Summary

The medtech industry’s call for a one-year delay to the Medical Device Regulation and for EU-wide exceptions from usual medical device rules was granted recently. But not for IVDs, where the situation is described as “grim.”

You may also be interested in...



EU IVDR: Bisazza Explains Why Regulators Must Act Now To Defuse ‘Ticking Timebomb’

Industry’s message may continue in a similar vein, but the urgency over the implementation of the EU IVDR has grown to a point where it is desperate for some solution to what it sees as an impending disaster for IVDs in the EU.

European Commission ‘Will Not Delay IVDR, Nor MDR Any Further’

It seems that the medical device and IVD industries are clutching at straws if they expect the European Commission to agree to further delays in the EU medtech regulations.

No Quick Fix When It Comes To EU Medtech Notified Body Designations

Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT126725

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel